Effectiveness and tolerability of the THC:CBD oromucosal spray as add-on measure in patients with severe chronic pain: analysis of 12-week open-label real-world data provided by the German Pain e-Registry (ETORO-PAIN)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

  Cross-sectional

Study drug and medical condition

• Name of medicine, other:
  Sativex
• Medical condition to be studied:
  Musculoskeletal pain

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  800

Study design details

• Main study objective:
  Main objective of this analysis is to gain further insight into their differential effects and the benefit-risk profile (BRP) of THC:CBD oromucosal spray given add-on to patients with elsewhere refractory severe chronic pain under real life conditions.
• Outcomes:
  Primary efficacy endpoint is an aggregated 9-factor symptom relief score (ASR-9) defined as a composite of nine efficacy parameters (at least 50% improvement of pain, pain-related disabilities in daily life, sleep, overall wellbeing, physical and mental quality-of-life, depression, anxiety and stress, each at end of observation vs. baseline). Safety endpoints is the spectrum of treatment emergent adverse reactions (TEAEs) and the proportion of related treatment discontinuations.
• Data analysis plan:
  Exploratory analysis of anonymized 12-week routine/open-label data of the German Pain e-Registry (GPR) on adult SCP patients, in whom a treatment with THC:CBD has been initiated in compliance with the current German prescribing regulations between March 10th and December 31st, 2017. No formal sample size analysis will be performed. Data analyses will be performed for all registered patients who took at least one dose of study medication and who had at least one post-baseline/post-dose measure (modified intent-to-treat approach). Analyses will be performed for patient samples with nociceptive, mixed or neuropathic pain identified with the modified 7-dimensional patient-reported pain detect questionnaire (PDQ7) to gain best insight into the effectiveness of THC:CBD in different pain mechanisms.